Director, Clinical Program Quality & Excellence (CPQE), Oncology

Takeda•Cambridge, MA

1d•$177,000 - $278,080•Onsite

About The Position

Shapes, at the asset-level, a risk based quality management model that elevates clinical program performance, strengthens regulatory confidence, and accelerates time to market by proactively reducing systemic compliance risks. Serves as a strategic quality leader at asset-level key governance bodies (e.g. Global Program Team, Clinical Sub-Team, Clinical Review Board), shaping portfolio decision making by providing objective insights on emerging risks, critical quality issues, and mitigation strategies that safeguard program continuity and asset value. Leads real-time inspection readiness at the asset-level, across all Study Execution Teams, driving operational discipline, cross-functional issue resolution, and sustained adherence to global GCP and regulatory expectations throughout end-to-end clinical trial delivery. Champions a culture of accountability, scientific rigor, and quality by design at the asset-level, influencing senior stakeholders and partners to adopt robust quality practices that protect patient safety, uphold data integrity, and support successful regulatory submissions worldwide.

Requirements

Scientific or allied health/medical degree (BSc required; MSc or PhD preferred).
Minimum of 10 years of progressive experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs.
Advanced expertise across the clinical development lifecycle, from R&D through commercialization and lifecycle management, with deep, hands‑on knowledge of GCP regulations and guidelines.
Experience in quality leadership roles, including quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, and complex investigation and remediation activities.
Dynamic and adaptable leadership style, combining a strong sense of urgency with the flexibility to operate effectively in fast‑changing, complex environments.
Strategic, creative, and resourceful, with an entrepreneurial mindset and a willingness to be hands‑on to drive impact and results.
Strong interpersonal skills and executive presence, with the ability to influence, align, and lead stakeholders at all organizational levels.
Strong communication skills, with experience representing teams and organizations in diverse, global, and high‑stakes settings.
Decisive, proactive, and well‑organized, with the ability to prioritize effectively and manage competing demands.
Open‑minded and appropriately risk‑tolerant, demonstrating humility, resilience, and comfort with challenge and constructive debate.
Unwavering integrity and ethical standards, with a strong commitment to patient safety, scientific rigor, and regulatory compliance.

Responsibilities

Responsible for quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality management strategies to drive compliance and de-risk clinical programs.
Responsible to lead escalation of quality issues, risks and mitigations to enable data-driven, quality and patient-centric decision-making at relevant governance levels (e.g. Global Program Team, Clinical Sub-Team, Clinical Review Board).
Lead investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events and deviations, applying robust root cause analysis to ensure effective resolution and prevention of recurrence.
Responsible to drive inspection readiness for assigned asset-level clinical programs in TAU, providing oversight to drive sustainable compliance embedded end to end in clinical programs.
Responsible to lead global GCP inspection strategy for assigned asset-level clinical programs, leading the planning for submission‑related inspections, representing Takeda as a Subject Matter Expert (SME) in clinical program quality oversight during regulatory interactions.
Responsible to develop and implement robust, risk-based audit strategy for assigned asset-level clinical development programs that enables early detection of potential quality issues with appropriate mitigations to reduce clinical program risks.
Responsible to support and mentor the CPQ team for assigned Study Execution Teams (SETs) in the development, implementation and refinement of a proactive quality oversight model, embedding real-time inspection readiness by driving proactive compliance, documentation quality and the framework for proactive investigation and cross‑functional resolution of quality events.
Responsible to contribute to the R&D Quality GxP Center of Continuous Improvement and Performance in CTD and PV through comprehensive approach in sharing insights and learnings throughout clinical program delivery.